Bezlotoxumab
- Generic Name
- Bezlotoxumab
- Brand Names
- Zinplava
- Drug Type
- Biotech
- Chemical Formula
- -
- CAS Number
- 1246264-45-8
- Unique Ingredient Identifier
- 4H5YMK1H2E
- Background
Bezlotoxumab is a fully humanized ImmunoglobulinG1 (IgG1) kappa monoclonal antibody that binds to Clostridium difficile toxin B and neutralizes its effects. First approved by the FDA on October 21, 2016, bezlotoxumab is used to reduce the recurrence of C. difficile infection. On November 22, 2016, the Committee for Medicinal Products for Human Use of the Eur...
- Indication
Bezlotoxumab is indicated to reduce the recurrence of Clostridioides difficile infection (CDI) in patients who are receiving antibacterial drug treatment for CDI and are at high risk for CDI recurrence. In the US, the drug is approved for use in patients one year of age and older. In Europe, it is approved in adults only.
- Associated Conditions
- Clostridium difficile infection recurrence
- Associated Therapies
- -
Bezlotoxumab Yielded Outcomes by Addressing Personalized Needs in Clostridioides Difficile Infection
- First Posted Date
- 2022-03-31
- Last Posted Date
- 2023-12-15
- Lead Sponsor
- Hellenic Institute for the Study of Sepsis
- Target Recruit Count
- 44
- Registration Number
- NCT05304715
- Locations
- π¬π·
2nd Department of Internal Medicine, University General Hospital of Alexandroupolis, Alexandroupoli, Greece
π¬π·2nd Department of Internal Medicine, Tzanneion General Hospital, Piraeus, Greece
π¬π·1st Department of Internal Medicine, AHEPA University General Hospital of Thessaloniki, Thessaloniki, Greece
Bezlotoxumab Versus FMT for Multiple Recurrent CDI
- First Posted Date
- 2021-10-13
- Last Posted Date
- 2023-03-28
- Lead Sponsor
- Leiden University Medical Center
- Registration Number
- NCT05077085
- Locations
- π³π±
Haaglanden Medical Center, Den Haag, Netherlands
π³π±Amsterdam University Medical Centers, AMC, Amsterdam, Netherlands
π³π±Leiden University Medical Center, Leiden, Netherlands
Bezlotoxumab as Secondary Prophylaxis for C. Difficile in High-risk Hospitalized Patients Exposed to Antibiotics.
- First Posted Date
- 2019-05-06
- Last Posted Date
- 2022-11-09
- Lead Sponsor
- Montefiore Medical Center
- Target Recruit Count
- 1
- Registration Number
- NCT03937999
- Locations
- πΊπΈ
Montefiore Medical Center, Bronx, New York, United States
Bezlotoxumab (BEZLO) In Addition To Standard Of Care (SOC) Vancomycin For The Treatment of Multi-Recurrent Clostridium Difficile Infection
- Conditions
- Interventions
- First Posted Date
- 2019-03-19
- Last Posted Date
- 2022-05-26
- Lead Sponsor
- University of Kansas Medical Center
- Target Recruit Count
- 4
- Registration Number
- NCT03880539
- Locations
- πΊπΈ
University of Kansas Medical Center, Kansas City, Kansas, United States
ICON-2: FMT and Bezlotoxumab Compared to FMT and Placebo for Patients With IBD and CDI
- Conditions
- Interventions
- First Posted Date
- 2019-02-04
- Last Posted Date
- 2024-12-11
- Lead Sponsor
- Brigham and Women's Hospital
- Target Recruit Count
- 61
- Registration Number
- NCT03829475
- Locations
- πΊπΈ
Brigham and Women's Hospital, Boston, Massachusetts, United States
Drug Development Updates
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